Computer System Validation Engineer

Stark Pharma; Indianapolis (IN); On-site; USD 80,000 - 100,000; Full time

Job summary

Stark Pharma is looking for a Validation Engineer in Indianapolis to support validation activities and ensure compliance with regulatory standards. The role involves leading document migration, performing equipment qualifications, and maintaining accurate documentation in a GMP-regulated environment. Candidates should have a Bachelor's degree and at least 6 years of experience in Computer Systems Validation (CSV) and pharmaceutical manufacturing. The position is 100% onsite.

Qualifications

• 6+ years of experience in Computer Systems Validation (CSV).
• 4+ years of experience in pharmaceutical manufacturing environment.
• Hands-on experience with equipment qualification and validation.

Responsibilities

• Lead migration of legacy validation documents into the Kneat digital platform.
• Perform equipment qualification for lab instruments.
• Execute temperature mapping studies using Ellab systems or similar equipment.
• Support Computer Systems Validation (CSV) activities.
• Assist Process Engineering teams to ensure project timelines are met.
• Ensure validation activities comply with GMP and regulatory requirements.
• Maintain clear and accurate documentation.

Skills

Computer Systems Validation (CSV)

Equipment qualification

GMP regulatory compliance

Documentation migration

Education

Bachelor's degree in Engineering, Science, or related field

Job description

Job Title: Validation Engineer

Location: Indianapolis / Bloomington, IN (100% Onsite)

Duration: Long term Contract

Interview Mode: Onsite (Local candidates preferred)

Overview

We are seeking a Validation Engineer with strong experience in Computer Systems Validation (CSV), equipment qualification, and GMP-regulated environments. The ideal candidate will support validation activities, documentation migration, and equipment qualification to ensure compliance with regulatory standards.

Key Responsibilities

• Lead migration of legacy validation documents into the Kneat digital platform, ensuring accuracy and compliance
• Perform equipment qualification for lab instruments (pH meters, thermal mixers, peristaltic pumps, nutating mixers, etc.)
• Execute temperature mapping studies, including work with Ellab systems or similar equipment
• Support Computer Systems Validation (CSV) activities and documentation
• Assist Process Engineering teams to ensure project timelines and milestones are met
• Ensure all validation activities comply with GMP and regulatory requirements
• Maintain clear, accurate, and compliant documentation

Required Qualifications

• Bachelor s degree in Engineering, Science, or related field
• 6+ years of experience in Computer Systems Validation (CSV)
• 4+ years of experience in pharmaceutical manufacturing environment
• Hands-on experience with equipment qualification and validation
• Strong knowledge of CSV principles and regulatory compliance
• Experience working in onsite, fast-paced environments